Basic information
Outline of the system
Pursuant to Supreme Decree No. 3/2010, a pharmaceutical product or drug is any substance intended for human use for the purpose of curing, mitigating, treating, preventing or diagnosing diseases or their symptoms. Pursuant to Supreme Decree No. 239/02, a cosmetic product is any preparation intended to be applied externally to the human body for purposes of beautification, modification of physical appearance or preservation of the normal physical and chemical conditions of the skin and its annexes.
Product coverage
Sanitary registration of the product: One-time registration issued by the Chilean Public Health Institute that guarantees quality, safety and efficacy. Sanitary authorization of establishment: Authorization granted by a health-related entity for the purposes established in a particular decision (storage, distribution, transfer, packaging, etc.). Customs destination certificate: Document allowing products to be moved from the customs area to the authorized sanitary establishment. Use and disposal: Decision allowing the health product to be used, transferred, assigned or sold for any reason.
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
This procedure is not intended to restrict the quantity or value of imports; its purpose is to certify compliance with current health regulations applicable to pharmaceutical and cosmetic products.
Questions for products under restriction as to the quantity or value of imports
The Public Health Institute has provided various instructions for each step required for processing. Links are provided below:
(a) Instructions for registering pharmaceutical products: https://ispch.cl/sites/default/files/prestacion/2012/03/instructivo_requ...
(b) Cosmetic product registration data sheet: https://www.ispch.cl/sites/default/files/prestacion/2009/12/4112001.pdf
(c) Instructions for authorizing establishments: https://ispch.cl/wp-content/uploads/2021/02/Instructivo-Autorizaci%C3%B3...
(d) Instructions for processing foreign trade operations associated with goods subject to sanitary control by the Public Health Institute: https://www.ispch.cl/wp-content/uploads/2021/01/3007-2020-OP-1.pdf
The system applies to products originating from which country?
This applies to all countries of origin and provenance of each pharmaceutical and cosmetic product.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
Decree having Force of Law (DFL) No. 725 (Health Code) delegates to the Chilean Public Health Institute responsibility for the sanitary control in Chile of pharmaceuticals (Article 96) and cosmetics (Articles 107 and 108), which, in order to be imported and distributed in the country, must first have their sanitary registration authorized by the Chilean Public Health Institute (Article 20 of Supreme Decree No. 3/2010 for pharmaceutical products and Article 4 of Supreme Decree No. 239/02 for cosmetic products).
For importation, the relevant customs destination certificate and certificate of use and disposal must be requested from the Institute, in accordance with Articles 2 and 3 of Law No. 18.164, which introduces amendments to customs legislation. Articles 98 and 99 of Supreme Decree No. 3/2010 on pharmaceutical products and Article 16 of Supreme Decree No. 239/02 on cosmetic products require a customs destination certificate and a certificate of use and disposal for importation and sale in the country.
Circular No. 3779 of 4 December 2015, issued by the Undersecretariat for Public Health, states that the Public Health Institute is in charge of issuing customs destination certificates for pharmaceuticals and cosmetics throughout the national territory.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Is it possible for the government to abolish the system without legislative approval?
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
What persons or firms are eligible to apply for a licence?
Any person may apply for an import licence, as long as the following elements are present: Sanitary registration authorized by the Public Health Institute, sanitary establishment authorized to store and distribute the product, and an account and password for the Public Health Institute's processing platform (GICONA).
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
Address
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Documentation requirements
What information is required in applications?
Applications must include the following information: importer, product imported, mode of transport, customs agent and product batch, among other elements.
What documents is the importer required to supply with the application?
Window of submission of an application
How far in advance of importation must application for a licence be made?
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
There are no limitations as to the period of the year during which the licence application may be submitted or the importation may take place.
Issuing the license
Can a licence be granted immediately on request?
If the invoice and transport document are available, the customs destination certificate can be issued in advance. It must be requested by the importer through the GICONA platform. It should be noted that each process has an associated cost, which can be consulted in the "Services" section of the Public Health Institute's web page.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
They may be issued prior to arrival in Chile, as long as an invoice and a transport document are provided.
Which administrative body is responsible for approving application of licences?
In this case, licences are considered only by the Public Health Institute.
Must the applications be passed on to other organs for visa, note or approval?
Are there any other conditions attached to the issue of a licence?
The issue of an import licence for pharmaceutical and cosmetic products is subject to other conditions:
(a) For narcotics and psychotropic substances, there is a requirement of prior authorization of the official import certificate by the Public Health Institute. This certificate determines how much of the product can be imported.
(b) For products that are not subject to quantitative restrictions, there may be sanitary restrictions previously established by the Public Health Institute (products the importation of which is prohibited, products subject to an international health alert).
Fees and other administrative charges
Is there any licensing fee or administrative charge?
Each service has a cost, which can be consulted in the "Services" section of the Public Health Institute's web page (https://www.ispch.cl/productos-y-servicios/prestaciones/)
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
Payment for these services is a condition for the issue of the associated licences.
Amount or rate?
Is it refundable?
It is non refundable.
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
Licences may be refused for incompleteness of background information or non-compliance with health regulations.
Are the reasons for any refusal given to applicants?
The importer is informed of the grounds for refusal in the pronouncements made by the Public Health Institute, which can be consulted and appealed through the Lobbying Law platform.
Have applicants a right of appeal in the event of refusal to issue a licence?
The importer is informed of the grounds for refusal in the pronouncements made by the Public Health Institute, which can be consulted and appealed through the Lobbying Law platform.
If so, to what bodies and under what procedures?
The importer is informed of the grounds for refusal in the pronouncements made by the Public Health Institute, which can be consulted and appealed through the Lobbying Law platform.
Importation
Are there any limitations as to the period of year during which importation may be made?
There are no limitations as to the period of the year during which the licence application may be submitted or the importation may take place.
What documents are required upon actual importation?
An invoice or purchase order for the product, a transport document or detention letter for the product, a certificate of analysis of origin, a decision authorizing importation for exceptional use, if applicable (for pharmaceutical products without sanitary registration, in accordance with Article 99 of the Health Code, the decision is issued by the Public Health Institute), and an official import certificate for drugs, narcotics or psychotropic substances, if applicable, authorized by the Public Health Institute.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Pursuant to Articles 180 and 183 of Supreme Decree No. 3/2010, a series control application is required for biological pharmaceutical products or those determined by the Public Health Institute. In addition, all imports are subject to what the Public Health Institute has determined previously. When the importation is completed, the importer is required to prepare the corresponding local analysis certificate and submit it to the Public Health Institute.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
The period of validity is subject to the provisions of each decision (sanitary registration and authorization of establishments). The customs destination certificate and the certificate of use and disposal do not have a defined validity.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
In accordance with Article 3 of Law No. 18.164, the Public Health Institute may establish a security period for the issue of the use and disposal certificate for all imports that require a detailed documentary review. There is no penalty for the non-utilization or partial utilization of the import licence.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
It is not possible to transfer an import licence from one importer to another, since these licences are subject to prior authorizations for sanitary registration and authorization of establishment. Moreover, it is not possible to sell the products without an authorized use and disposal certificate. The rejection of a use and disposal request leaves the importer with the option of re-exporting the merchandise to the place of origin or destroying it. Notwithstanding the above, the importer may appeal the rejection of a use and disposal request, and have the request authorized, by navigating to "Clarifications on use and disposal decisions (authorized and/or rejected)" on the GICONA platform.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
To receive foreign exchange, the importer must obtain an authorized use and disposal certificate, since this document will enable the importer to sell the product in the country.